Compounded Medication Informed Consent

What is Pharmaceutical Compounding?

Compounding is the process of creating a customized medication by a licensed pharmacist to meet the unique needs of an individual patient. Compounded medications are prepared based on a prescription from a licensed healthcare provider and may include:

Custom dosage forms (e.g., creams, gels, capsules, injections)
Specific dosage strengths not commercially available
Medications without certain allergens or additives
Combinations of medications in a single preparation
Medications that are in shortage or discontinued by manufacturers

Important Differences from FDA-Approved Medications

Key Understanding:

Compounded medications are NOT FDA-approved drug products. This means they have not undergone the same rigorous testing and approval process as commercially manufactured medications.

FDA-Approved Medications	Compounded Medications
Manufactured in FDA-inspected facilities	Prepared in state-licensed or FDA-registered pharmacies
Undergo clinical trials for safety and efficacy	Based on FDA-approved ingredients but the specific preparation is not tested
Standardized potency and purity testing	Testing requirements vary by pharmacy type (503A vs 503B)
Consistent manufacturing across all batches	May have more variability between batches
Available in fixed, standard dosages	Can be customized to individual patient needs

Types of Compounding Pharmacies

503A Pharmacies (Traditional Compounding Pharmacies)

Regulated primarily by state boards of pharmacy
Prepare medications for individual patients based on prescriptions
May dispense directly to patients or to prescribers for office use in limited quantities
Generally do not distribute across state lines

503B Outsourcing Facilities

Registered with and inspected by the FDA
Subject to Current Good Manufacturing Practice (cGMP) requirements
Can produce larger quantities without individual prescriptions
Required to report adverse events to the FDA
Generally considered to have more stringent quality controls

Your compounding pharmacy type:

Why a Compounded Medication is Being Prescribed

Your healthcare provider is prescribing a compounded medication for one or more of the following reasons:

The commercially available product is in shortage or unavailable

You require a customized dosage not commercially available

You have allergies to ingredients in the commercial product

You require a different dosage form (e.g., injection instead of tablet)

The medication is only available as a compounded preparation

Other: _______________________________________________

Potential Risks of Compounded Medications

Sterility concerns: Improperly compounded sterile preparations (especially injectables) can lead to serious infections
Potency variability: The amount of active ingredient may vary more than in FDA-approved products
Contamination: Risk of contamination with bacteria, mold, or other substances
Stability issues: Compounded medications may have shorter shelf lives or different storage requirements
Limited safety data: Specific formulations have not been tested in clinical trials
No manufacturer recall system: Compounded preparations are not subject to the same recall procedures as FDA-approved drugs

Storage and Handling Instructions

Follow all storage instructions provided by the pharmacy (refrigeration, protection from light, etc.)
Do not use medication past the beyond-use date assigned by the pharmacy
Inspect injectable medications for particulates, discoloration, or leakage before each use
Use proper aseptic technique when preparing and administering injectable medications
Dispose of unused medication properly according to pharmacy instructions

Patient Acknowledgments

By signing below, I acknowledge and confirm that:

I understand that compounded medications are NOT FDA-approved products

I understand that compounded medications have not undergone the same testing as commercially manufactured drugs

My prescriber has explained why a compounded medication is being recommended for my situation

I understand the potential risks associated with compounded medications

I understand that an FDA-approved alternative may or may not be available

I will follow all storage and handling instructions provided by the pharmacy

I will report any adverse reactions or quality concerns to my prescriber and pharmacy

I understand that my insurance may not cover compounded medications

I voluntarily consent to receiving a compounded medication